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How Intraoperative pain indices Predict Post-operative Outcomes in children younger than 2 years: HIPPO study

How Intraoperative pain Predicts Post-operative Outcomes in children: HIPPO study- A prospective observational pilot study using newborn infant parasympathetic evaluation (NIPE)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001459112
Enrollment
50
Registered
2019-10-22
Start date
2021-04-01
Completion date
2021-10-31
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will explore whether intraoperative NIPE values correlate to the level of post-operative pain and the amount of analgesia required after elective surgery in children. This has not yet been explored, and could ultimately result in less pain and distress to children and their carers.

Interventions

Patients will undergo elective surgery according to local guidelines and practice (i.e. inguinal hernia repair, orchidopexy, patent processus vaginalis ligation for hydrocele, circumcision, umbilical hernia repair and excision of skin lesions). The NIPE monitor will be connected to the electrocardiogram monitor, to analyse the heart rate variability (and thus parasympathetic tone), producing a value correlating to pain. We will be documenting the mean intraoperative NIPE value, as well as the a

Patients will undergo elective surgery according to local guidelines and practice (i.e. inguinal hernia repair, orchidopexy, patent processus vaginalis ligation for hydrocele, circumcision, umbilical hernia repair and excision of skin lesions). The NIPE monitor will be connected to the electrocardiogram monitor, to analyse the heart rate variability (and thus parasympathetic tone), producing a value correlating to pain. We will be documenting the mean intraoperative NIPE value, as well as the absolute values at the following specified time points: endotracheal intubation, venous cannulation, peripheral nerve block administration, skin incision, and skin closure. Following these procedures, post-operative outcomes will be assessed. Patients will be observed from entering the post anaesthetic care unit until discharge home or to the surgical ward.

Sponsors

Monash Children's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
0 to 2 Years
Healthy volunteers
No

Inclusion criteria

All children below 2 years of age, with no significant associated co-morbidities (American Society of Anaesthesiologists class 1 and 2), who are undergoing elective surgical procedures will be included. This may include but is not limited to: inguinal hernia repair, orchidopexy, patent processus vaginalis ligation for hydrocoele, umbilical hernia repair and excision of skin lesions.

Exclusion criteria

Children who have cardiac, respiratory or neurological conditions will be excluded, as well as those with a history of premature delivery.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026